What Happened to Progressive Hair Dyes Made With Lead

Progressive hair dyes, which darken gray hair a little with each use, were made with lead acetate in the United States for decades. The FDA repealed lead acetate's approval as a color additive in a final rule published on October 31, 2018. A manufacturer's objections put the rule on hold, and the repeal finally took effect on January 6, 2022. Bismuth citrate, a different metal salt, is still an approved color additive, and the FDA noted that it was already being used in place of lead acetate.

This post is part of our guide to ways to cover gray hair.

What a progressive dye is

In a 2021 notice, the FDA described progressive hair dyes as products that, "when applied to gray hair, gradually change the color with repeated applications." It cited one maker's directions: apply the dye daily until you reach the shade you want, which usually took 2 to 3 weeks, then once or twice a week to keep it.

A 2009 review in the Journal of Emergencies, Trauma and Shock explains that progressive dyes change hair "from light straw color to almost black" by reacting with the sulfur of hair keratin and by oxidizing on the hair surface. A 2022 paper in the journal Sensors adds that the reaction forms a mixture of metal oxides and insoluble sulfide, and that mixture is what slowly darkens white strands.

Our explainer on gradual hair color covers the whole category.

1980: lead acetate is approved

On October 31, 1980, the FDA listed lead acetate as a color additive for coloring hair on the scalp, at up to 0.6 percent lead. The listing came with restrictions and a required cautionary statement on the label.

The FDA based its decision partly on a skin absorption study. From it, the agency estimated that people who applied the dye up to twice a week absorbed an average of 0.3 micrograms of lead a day, an amount it called "miniscule" at the time.

2017: a petition asks the FDA to look again

In 2017, a group of health and environmental organizations petitioned the FDA to repeal the listing. They argued that lead harms many body systems even at low levels, and that lead acetate applied to the scalp is not safe.

2018: the FDA repeals the approval

The FDA agreed. In a final rule published in the Federal Register on October 31, 2018 (83 FR 54665), it said new data showed there was no longer a reasonable certainty of no harm from this use. Its reasons included:

• No known safe level. The FDA said no evidence was available to determine a safe level of exposure to lead. It also cited the CDC's statement that there is no safe blood lead level in children.
• A flawed 1980 study. The skin study used 0.12 or 0.18 percent lead, three to five times lower than the 0.6 percent allowed. It tested eight men aged 20 to 35, while most users were typically 50 or older, and it used 8 to 10 square centimeters of forehead skin instead of a full scalp of approximately 580.
• Lower blood lead levels today. Blood lead levels in the United States had dropped a great deal since 1980. The rule noted a median of 0.88 micrograms per deciliter for adults in 2015 to 2016.
• Lead on hands and surfaces. A study the FDA reviewed found lead residue on users' hands and on combs, dye containers, hair dryer handles, faucets and telephones after use, showing that lead could transfer to other surfaces.

The rule was set to take effect on December 3, 2018.

2019 to 2021: objections put the rule on hold

A company that made lead acetate hair dyes filed objections and asked for a hearing. Under US law, filing objections stays a rule, which means it cannot take effect until the FDA acts on them. Because the regulation had already been removed on December 3, 2018, the FDA put it back on April 1, 2019 (84 FR 12081). The FDA said this step did not change its safety conclusion.

On October 8, 2021, the FDA published its response (86 FR 56183). It reviewed 19 numbered objections and denied the requests for a hearing. The FDA said the objections did not raise a genuine and substantial issue of fact, and did not provide new scientific data showing a safe level of lead exposure. In the FDA's notices, the delay of more than three years comes from this objection process.

2022: the repeal takes effect

The repeal took effect on January 6, 2022. The FDA said it would use enforcement discretion for 12 months after that date, to give companies time to use up existing stock and reformulate.

To help people spot the old products, the FDA said to check the label for lead acetate as an ingredient, or for a warning such as "For external use only. Keep this product out of children's reach."

Outside the United States

Other regulators also restrict lead in cosmetics. Health Canada says that exposure to lead from cosmetics used to come from progressive hair dyes with lead acetate, and that lead acetate is now not acceptable in cosmetic products in Canada. Regulation (EC) No 1223/2009, the cosmetics law written by the EU and still used in the UK, puts "lead and its compounds" on its list of substances banned from cosmetics.

What gradual dyes can use now

The category still has approved options. The FDA lists two color additives for hair that are "used in hair dyes that may darken hair gradually with repeated applications": henna, from the Lawsonia plant, and bismuth citrate.

Bismuth citrate has been listed since 1978 (21 CFR 73.2110). It may be used in cosmetics that color hair on the scalp at up to 2.0 percent, but not on eyelashes, eyebrows or body hair. Its label must tell users to keep it away from children, not to use it on a cut or scraped scalp, and to wash their hands after each use. When the FDA repealed lead acetate, it noted that bismuth citrate was already being used as an alternative in hair dye products sold in the United States and other countries.

A 2014 review in Actas Dermo-Sifiliográficas warns that metallic dyes made with silver nitrate or lead salts are incompatible with hydrogen peroxide, the developer in permanent dye. If you have used a progressive product, tell your colorist before any permanent color.

If you shop for gradual color today

• Read the ingredient list. Lead acetate is no longer allowed in hair dye sold in the United States.
• Read the warnings. Products with bismuth citrate must carry the warning described above.
• Test first. The FDA advises a skin patch test every time before you dye your hair. Our page on hair dye allergies and patch tests explains how.
• Compare the other options. Permanent, demi-permanent and semi-permanent dyes work in different ways. See permanent, demi-permanent and semi-permanent dye.

LIUMIQ is developing a gradual color product for gray hair. It is not for sale yet. Join the waitlist to follow the work.